RC - REGULATORY COMPLIANCE - CSV - Jama Connect System - Senior

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EY – GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance – Validation Consultant (Jama Connect System) – Senior   As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance Senior Consultant actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you will consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives.     The Opportunity   We are seeking an experienced Validation Consultant – Computerized System Validation (CSV) to lead validation and compliance for JAMA connect system for global pharmaceutical clients. The ideal candidate will ensure compliance with global regulatory standards (FDA, EMA, MHRA) and drive strategic initiatives for business process transformation and operational excellence .     Your Key Responsibilities

Support validation and compliance activities across GxP and non-GxP systems, aligning with global regulatory requirements and client objectives. Hands-on experience in validating Jama Connect and managing end-to-end requirements lifecycle, traceability, and CSV documentation (URS, FRS, Traceability Matrix) while ensuring adherence to GxP and regulatory compliance standards. Define and drive CSV/CSA strategies, enabling transition from traditional validation to risk-based assurance models. Integrate validation into Agile delivery models, ensuring compliance is embedded within iterative development cycles. Conduct impact assessments, gap assessments, and remediation for legacy and transforming systems. Author and review deliverables including URS, FRS, Risk Assessments, Validation Plans, IQ/OQ/PQ protocols, Traceability Matrix, and Summary Reports. Ensure data integrity and inspection readiness across systems. Coach and guide project teams on proper usage of templates, documentation expectations, and quality standards.

Bachelor’s or Master’s degree in Biotechnology, , Engineering, or related field. 4-7 years in performing CSV activities within the pharmaceutical, life sciences or consulting organizations Strong understanding of regulatory requirements including, GAMP 5, 21 CFR Part 11, Annex 11 Consulting or client‑facing experience preferred. Excellent communication, documentation, and stakeholder management skills.

Must-Have Skills & Attributes

Hands-on experience with Jama Connect, including requirements management, traceability, and validation within regulated (GxP) environments. Strong Expertise in CSV/CSA documentation: Gap Analysis, URS, FRS, IQ/OQ/PQ, Risk Assessments, Traceability Matrix, Validation Plans. Experience working in Agile delivery models Understanding of AI/ML lifecycle, governance and validation skills Strong stakeholder management and client facing skills, with ability to collaborate across business, IT and quality teams Strong problem solving and communication skills

Good-to-Have Skills & Attributes

Exposure to business development activities and client engagement strategies. High attention to detail and analytical thinking. Familiarity with emerging regulatory trends, such as CSA or digital validation approaches. Adaptability to changing regulatory and business environments.

Preferred Certifications

ISO 9001:2015 Lead